A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628

NCT06840925 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: PRAX-628-104
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I clinical trial to evaluate the relative bioavailability of PRAX-628 tablet formulation compared to capsule formulation

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules

  Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)

  28 days

• To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules

  Area under the plasma concentration time curve from time zero to infinity (AUCinf) of a single dose of PRAX-628 40 mg tablet (test), and the same dose delivered with PRAX-628 10 mg capsules (reference)

  28 days

Secondary Outcomes (11)

• To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules

  28 days

• To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules

  28 days

• To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules

  28 days

• To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules

  32 days

• To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules

  32 days

Study Arms (2)

Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules

EXPERIMENTAL

40 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally.

Drug: PRAX-628

Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet

EXPERIMENTAL

4×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally.

Drug: PRAX-628

Interventions

PRAX-628 DRUG

Once daily oral

Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules; Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2
• Is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
• All females have a negative pregnancy test and are not planning to get pregnant for the duration of the trial
• Female of non-childbearing potential by reason of surgery or at least 1 year post menopause

You may not qualify if:

• Any clinically significant abnormalities, medical, or psychiatric conditions identified by a detailed medical history, or physical examination
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. Examples of such conditions include (but are not limited to):
• History of inflammatory bowel syndrome, gastritis, gastrointestinal or rectal bleeding
• History of major gastrointestinal tract surgery (ie, gastrectomy, bowel resection, cholecystectomy etc.)
• History or evidence of pancreatic injury or pancreatitis
• History or presence of impaired renal function supported by estimated glomerular filtration rate \[eGFR\]\<60 mL/min/1.73m2 or clinically significant abnormal urinary constituents (eg, protein)
• History of cancer except for nonmelanoma skin cancer resected \>2 years ago and that has been definitively treated and considered cured.
• History of any lifetime suicide attempt or active suicidal ideation with intent as indicated by a "Yes" response to either Question 4 or 5 on the C-SSRS "Baseline/ Screening" version
• History of left bundle branch block, arrhythmias, Brugada syndrome, congenital heart disease, familial short QT syndrome, or family (first degree relative) history of sudden death, ventricular or clinically significant arrhythmias, including idiopathic ventricular fibrillation.
• Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position
• Abnormal vital signs after at least 5 minutes resting in the supine position:
• Has any of the following: a serum total bilirubin value \>1.1× the upper limit of normal (ULN), a serum alanine aminotransferase (ALT) value \>1.5×ULN, or aspartate aminotransferase (AST) value \>1.5×ULN
• Serology test positive for human immunodeficiency virus (HIV), or hepatitis B or C
• Known allergy or hypersensitivity to any component of the formulation of PRAX 628 or history of severe allergy or anaphylaxis to a drug, food, or other exposure
• Use of any experimental or investigational drug or device within 30 days prior to the first dose of study drug or 5 times the terminal half-life of the drug, whichever is longer

Sponsors & Collaborators

• Praxis Precision Medicines: lead

Study Sites (1)

Nucleus Network Melbourne

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Director, Clinical Development

  Praxis Precision Medicines

  STUDY DIRECTOR

Central Study Contacts

Head of Pharmacovigilance

CONTACT

617-300-8460; clinicaltrials@praxismedicines.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 21, 2025
• Study Start: March 24, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

AU (1)